Materials
Unapproved material never reaches the scale.
Prevent, not just record, the use of unapproved, expired or incorrectly weighed material, and keep the genealogy and balance of every batch.
What it does
From the supplier lot to the batch balance.
Quality status, formula, dispensing, genealogy and reconciliation share a single data chain.
Material lots
- Internal lot linked to the supplier lot
- Frozen expiry date, showing whether the supplier declared it or it was calculated
- Quarantine, approved, rejected, on hold, depleted and destroyed statuses
- Immutable history with mandatory reason and Part 11 signature
Formula and dispensing
- Versioned formula with components and tolerances, scaled to the actual batch size
- Guided dispensing with real-time weight validation
- Second-person verification
- FEFO suggestion: picking another lot requires a justification
Traceability and balance
- Backward and forward genealogy down to the supplier lot and its certificate
- Shows where the chain breaks, if it does
- Reconciliation and yield against the formula range
- Controlled material: losses require a signing witness
Connected
It shares the record with the rest of the suite.
Modules aren’t integrated through exports: they work on the same batch data.
The certificate of analysis is required to approve a material lot.
QMSQuality managementSupplier qualification is checked on approval, and out-of-range yield opens an event.
EQEquipmentScale calibration status is checked before weighing.
CPVContinued process verificationBatch yield feeds continued process verification.
Compliance
Regulations it supports.
Electronic signatures and the audit trail are the same across the suite.
See the compliance matrix- GMP
- Only approved materials used, lot identification and batch reconciliation.
- 21 CFR Part 11
- E-signatures to approve, reject or destroy lots and to approve formulas.
- GS1
- Lot identification.
See dispensing that won’t let you get it wrong.
We’ll walk you through the module with a case like yours and show how it connects to what you already use.